BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLANAV OI

    MDR report key: 8286014 · Received January 29, 2019

    Report

    Report Number
    2134265-2019-00518
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    September 17, 2018
    Report Date
    January 29, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    REPORTABLE UPON ANALYSIS COMPLETED ON (B)(6) 2019. A INTELLA NAV OI A SELECTED FOR A PROCEDURE. HOWEVER, IT WAS REPORTED THAT THE ABLATION PARAMETERS WERE LOST DURING ABLATION. THIS MADE IT IMPOSSIBLE TO PERFORM RADIOFREQUENCY. THE PROCEDURE WAS COMPLETED BY CHANGING THE CATHETER. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BODY FLUID INGRESS AT THE BUTT BOND. VISUAL INSPECTION REVEALED THAT THE BUTT BOND SEAL IS SPLIT. DISTAL END HAS A SLIGHT CURVE TO THE RIGHT. DRIED BODY FLUID FOUND ON THE HANDLE AND MAIN BODY TUBING AND DISTAL END. DRIED SALINE FOUND ON THE DISTAL END AND INSIDE THE IRRIGATION PORTS. ELECTRICAL CONTINUITY CHECKS REVEALED NO ELECTRICAL SHORTS OR OPENS, AS CHECKED MANUALLY USING A MULTI-METER AND BREAKOUT BOX. ALL ELECTRODES, SENSOR AND THERMOCOUPLE RESISTANCES MEASURED IN SPEC AND WERE TYPICAL. THE STEERING KNOB AND THE TENSION CONTROL KNOB FUNCTIONED PROPERLY ON BOTH LOCK AND UNLOCK POSITIONS. NO ABNORMAL RESISTANCE WAS FELT WHEN ACTUATING THE STEERING MECHANISM. ABLATION WAS ATTEMPTED BY USING A MAESTRO GENERATOR 4000, A METRIQ PUMP, AND A TANK OF 37C SALINE SOLUTION. THE DEVICE WAS FOUND WITHIN SPECIFICATIONS. THE DISTAL END WAS TO BE OPENED TO SEARCH FOR SIGNS OF FLUID INGRESS THROUGH THE BUTT BOND. AS RING 1 WAS REMOVED, SALINE SQUIRTED OUT OF THE WIRE FEED-THRU HOLE IN THE TUBING. NO FURTHER DISSECTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77876 INTELLANAV OI INTELLANAV OI OAE BOSTON SCIENTIFIC CORPORATION M004EPTR96200 0021677137

    Patients

    Seq Age Sex Outcome Treatment
    1